Central Serous Chorioretinopathy and Micropulse Laser Treatment

Central Serous Chorioretinopathy Clinical Trial

— LEVEO  

Official title:

Central Serous Chorioretinopathy and Micropulse Laser Treatment: Evaluation of Morphological and Functional Recovery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06346405
• Other study ID #: 10
• Status: Recruiting
• Start date: May 31, 2023
• Est. completion date: May 31, 2025

Study information

• Verified date: March 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Maria Cristina Savastano, MD, PhD
• Phone: (+39)063015
• Email: mariacristinasavastano[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To evaluate choroidal and choriocapillaris changes in patients with central serous chorioretinopathy, undergone sub threshold micropulse laser treatment, following any improvement with conservative therapy with Acetazolamide and/or Eplerenone

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosis of central serous chorioretinopathy (CSC) with no response to conservative therapy, consisted in Acetazolamide and Eplerenone after six months.
• Foveal serous retinal detachment for at least 6 months.
• Minimum age of 18 years old at the screening time
• Reading and comprehension skills of informed consent

Exclusion Criteria:

• Previous retinal treatment for CSC, except for Acetazolamide and Eplerenone
• No diffuse retinal epitheliopathy
• Other concomitant ocular diseases, such as age related macular degeneration, diabetic retinopathy, choroidal neovascularization
• Not controlled glaucoma with eyedrops, or advanced glaucoma
• Myopia or hypermetropia greater than 6 diopters
• Opacities of dioptric media
• Low quality of optical coherence tomography (OCT) and OCT-Angiography scans
• Low quality images of Fluorescein angiography and indocyanine green angiography
• No written consensus signed.

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy

Intervention

Other:
• Subthreshold Micropulse Laser Treatment
Subthreshold micropulse laser treatment consists in 33 spots of 100 microns, distance among each spot of 2.50 microns, duration of 200 sec, power of 250 milliwatt (mW) duty cycle 5%.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Agostino Gemelli, IRCCS	Roma	R

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vessel density changes	Evaluation of changes in vessel density of choriocapillaris by optical coherence tomography (OCT) angiography before and after treatment	12 and 24 months
Secondary	Choroidal thickness	Evaluation of changes in choroidal thickness before and after treatment.	12 and 24 months
Secondary	Choroidal thickness and vessel density	Correlation among changes in choroidal thickness and changes in vessel density of choriocapillary with best corrected visual acuity.	12 and 24 months
Secondary	Qualitative analysis of retino-choroidal vascularization with identification of vascular pattern	To qualitatively evaluate the vascular patterns using optical coherence tomography (OCT) - angiography and to verify if a particular one is associated with a greater response to subthreshold micropulse laser treatment.	12 and 24 months
Secondary	Metamorphopsia	Evaluation of quantitative improvement of metamorphosia by M-CHARTS after treatment.	12 and 24 months
Secondary	Metamorphopsia and BCVA	Correlation between metamorphopsia and best corrected visual acuity (BCVA)	12 and 24 months
Secondary	Ellipsoid Zone Integrity	Evaluation of ellipsoid zone integrity by optical coherence tomography (OCT) B scan.	12 and 24 months
Secondary	Improvement in retinal function	To evaluate the potential improvement in retinal function with mean retinal sensitivity and microperimetry.	12 and 24 months
Secondary	Quality of life (QoL)	Evaluation of correlation among quality of life parameters assessed by visual function questionnaire (VFQ), stress and relapses and visual acuity.	12 and 24 months
Secondary	Ellipsoid zone and BCVA	To evaluate the association between ellipsoid zone integrity on optical coherence tomography (OCT) B scan and best corrected visual acuity (BCVA)	12 and 24 months